To assess the feasibility and effects on blood pressure and cardiac and renal function of RSD after renal transplantation.
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Procedural success (4-8 ablation per renal artery) without adverse events
during hospitalization (death, renal artery dissection, renal or peripheral
embolisation, major bleeding).
Blood pressure reduction at 6 months, by 24-h RR measurement.
Secondary outcome
Efficacy endpoints: clinical cardiovascular events, systemic and imaging
parameters of left ventricular remodelling, laboratory parameters of
sympathetic and RAAS activation, laboratory assessment of parameters of
cardiovascular fibrosis and gene expression of cardiovascular fibrosis
Background summary
Renal Sympathetic Denervation (RSD) has emerged as an effective therapy to
treat drug-resistant hypertension. Patients after renal transplantation have
their native kidneys in situ causing hypertension which is the most important
predictor of transplant survival. RSD of the native kidneys may be an effective
tool to control hypertension after renal transplantation.
Study objective
To assess the feasibility and effects on blood pressure and cardiac and renal
function of RSD after renal transplantation.
Study design
Feasibility study.
Intervention
Bilateral renal sympathetic denervation with the Symplicity Catheter System*,
(Medtronic Ardian).
Study burden and risks
Patients applying for this therapy undergo a screening protocol to evaluate
baseline status, including laboratory assessment, 24-hours urine investigation,
echocardiograpy, 24-hours Holter monitoring and heart rate variability
assessment. During the procedure intravascular echo (IVUS) of the renal
arteries will be performed.
Iodine-containing intravenous contrast, used during the catheterization, may
result in worsening of renal function due to contrast nephropathy. The risk of
contrast nephropathy is higher in patients with impaired renal function.
However, this risk is low after pre- and posthydration with NaCl 0.9%. We will
implement a hydration protocol for patients with eGFR <45 ml/min according to
current CBO-guidelines (2007). Iodine-containing contrast may lead to allergic
contrast reactions, which occur in less than 5% of the patients and can
effectively treated by medication and supportive care. The risk of dissection
during the IVUS procedure is very low, since the renal arteries have a large
calibre. In case it may happen, this can be effectively treated by stent
placement. The risk of the procedure itself is low and comparable to the
general risk of any arterial catheterization. Most important risks are bleeding
complications at the puncture site (<5% of the cases, rarely life-threatening
or requiring surgery), or clinically relevant peripheral embolization (very
rare). All other above mentioned tests are non-invasive and have negligible
risks for the patient. The thorough assessment of the patient by these
investigations may lead to a better patient selection in the future and may
lead to better understanding of the cardiovascular effects of the treatment.
Albinusdreef 2
Leiden 2332 ZA
NL
Albinusdreef 2
Leiden 2332 ZA
NL
Listed location countries
Age
Inclusion criteria
Hypertension despite 2 or more anti-hypertensive drugs
Functioning transplant kidney in situ
Exclusion criteria
Renal artery stenosis of native of transplant reanl arteries
Primary hyperaldosteronisme
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40083.058.12 |